CHMP positive for Awiqli (once-weekly basal insulin icodec) for treatment of diabetes in adults.- Novo Nordisk.
The positive CHMP opinion is based on results from the ONWARDS phase IIIa clinical trial programme. Once-weekly basal insulin icodec achieved superior blood sugar reduction (measured by a change in HbA1c) and superior Time in Range (time spent within recommended blood sugar range), compared with daily basal insulin in people with type 2 diabetes.
In people with type 2 diabetes who have not previously been treated with insulin, overall observed rates of clinically significant or severe hypoglycaemia were below one event per patient-year of exposure with both once-weekly basal insulin icodec and comparators. In people with type 1 diabetes, once-weekly basal insulin icodec demonstrated non-inferiority in reducing HbA1c with a statistcally significant higher estimated rate of severe or clinically significant hypoglycaemia compared with insulin degludec. Across the programme, once-weekly basal insulin icodec appeared to have a safe and well-tolerated profile.
“We believe that by reducing the number of basal insulin injections from seven to one per week, Awiqli has the potential to have a significant impact and improve treatment for people living with diabetes,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “We are committed to driving innovation in diabetes treatment, and Awiqli has the potential to become the insulin of choice for people with type 2 diabetes initiating insulin treatment.”
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
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